VERYCLEAR 1515

GUDID 00852588007069

SINGLE LUMEN GAS EVACUATION PORT

LEXION MEDICAL, LLC

Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use

• Primary Device ID: 00852588007069
• NIH Device Record Key: 24094d22-7da2-4547-8f02-fdc1befde3f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERYCLEAR
• Version Model Number: 1515
• Catalog Number: 1515
• Company DUNS: 848693730
• Company Name: LEXION MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852588007069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132203

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

[00852588007069]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-02-15

Devices Manufactured by LEXION MEDICAL, LLC

• 00852588007243 - Standard filtered tube set: 2022-06-10 Standard insufflation tube set, filtered, single use
• 00852588007229 - AP50/30: 2020-11-10 High Flow Insufflator
• 00852588007069 - VERYCLEAR: 2020-01-09SINGLE LUMEN GAS EVACUATION PORT
• 00852588007069 - VERYCLEAR: 2020-01-09 SINGLE LUMEN GAS EVACUATION PORT
• 00852588007083 - INSUFLOW SYNERGY PORT: 2020-01-09 5mm GAS CONDITIONING PORT
• 00852588007090 - INSUFLOW SYNERGY XL PORT: 2020-01-09 8mm GAS CONDITIONING PORT
• 00852588007106 - INSUFLOW SYNERGY XL PORT: 2020-01-09 10mm GAS CONDITIONING PORT
• 00852588007113 - INSUFLOW SYNERGY XL PORT: 2020-01-09 12mm GAS CONDITIONING PORT
• 00852588007120 - INSUFLOW SYNERGY XL PORT: 2020-01-09 8mm X 130mm GAS CONDITIONING PORT